AstraZeneca’s Imfinzi bladder cancer filing bags FDA Priority Review

AstraZeneca and Daiichi Sankyo's Enhertu received NICE approval for HER2-positive breast cancer treatment. The drug, priced at £1,455 per 100mg vial, was initially rejected due to cost but gained approval after NICE's valuation methodology change. It extends patient lifespans by an average of seven months.

AstraZeneca (AZN) announced the FDA granted Priority Review for its IMFINZI-enfortumab vedotin regimen for muscle-invasive bladder cancer. The application is based on positive Phase 3 trial results showing improved event-free and overall survival. The FDA decision is expected in Q4 2026. AZN stock closed at $164.56, up 0.75%.

Several biotech and pharma companies received regulatory approvals. MESO, LLY, ANIP, GRAL, AZN, TLSI, ABBV, RHHBY, MRK, AMRX, and ABEO gained approvals for various treatments. ABBV and RHHBY also announced strategic partnerships. LLY, GRAL, and ABBV saw notable stock price changes.

AstraZeneca (AZN) received FDA Priority Review for IMFINZI plus enfortumab vedotin to treat muscle-invasive bladder cancer. The application follows Phase III VOLGA trial results showing improved survival rates. The FDA decision is expected in Q4 2026, with reviews ongoing in other regions.

The FDA granted Priority Review to AstraZeneca's combination therapy of IMFINZI and enfortumab vedotin for muscle-invasive bladder cancer. The decision is based on the VOLGA Phase III trial, which showed significant improvements in event-free and overall survival. If approved, the regimen could become a new standard of care, with a regulatory decision expected in Q4 2026.

AstraZeneca has registered a new hypertension drug, Baxfendy, in Russia. The drug is approved as an adjunctive therapy for patients not achieving sufficient blood pressure reduction with three or more medications, according to the company's medical director in Russia and Eurasia.